We are looking for a Regulatory Affairs Therapy Lead to drive strategy and regulatory processes for products within the defined Therapy Areas
Job Summary
We are looking for a Regulatory Affairs Therapy Lead to drive strategy and regulatory processes for products within the defined Therapy Areas.
At AstraZeneca UK, we are committed to accelerating the position of the UK as a global centre of excellence in life sciences and redefining healthcare through fast and equitable access to the most effective medicines.
We offer a flexible working environment balancing office presence with individual flexibility to inspire life-changing medicines.
Matching Summary
We are looking for a Regulatory Affairs Therapy Lead to drive strategy and regulatory processes for products within the defined Therapy Areas.
Skills & Requirements
Must-have
Regulatory strategy development
UK regulatory compliance
Project leadership and line management
Clinical trial approval delivery
Knowledge of MHRA requirements
Negotiation and leadership skills
Nice-to-have
Post-graduate qualification
Therapy area expertise in oncology
Experience with orphan drug applications
Experience with paediatric indications
Experience with clinical trial submissions
Flexible in-person working
Key Requirements
Life Sciences Degree or professional qualifications
Significant regulatory affairs experience in UK-based global pharmaceutical company
Line management experience
Operational regulatory experience in commercial pharmaceutical roles